chronic kidney disease 3-5th stage
Conditions
Interventions
Sponsors
Southern Medical University Sinowest Medical Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the 2012 KDIGO Chronic Kidney Disease Clinical Practice Guidelines CKD 3-5 diagnostic criteria; 2. The TCM syndrome type conforms to the syndrome differentiation standard of spleen-kidney qi deficiency, turbid toxin and blood stasis; 3. Age 18-70 years old (including 18 years old and 70 years old); 4. Infection, acidosis, electrolyte imbalance, hypertension, etc. are effectively controlled (Bp<140/90mmHg); 5. If ACEI/ARB drugs are used, stable dose treatment is required for more than 2 weeks (inclusive); 6. No treatment with traditional Chinese medicine or proprietary Chinese medicine within 1 month before participating in the clinical trial; 7. The lead-in period is 4 weeks. At the beginning of the lead-in period and the end of the lead-in period, the patients must undergo the following tests respectively. Only those who meet the standards for both test results can enter the test: eGFR<60mL/(min/1.73m2), Bp<140 /90mmHg; 8. The subjects voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Coronary heart disease, myocardial infarction, severe arrhythmia, malignant tumor, serious complications such as liver, kidney, hematopoietic system, and severe mental disorders; 2. Acute and chronic nephritis, acute kidney injury, recent history of using nephrotoxic drugs; 3. Patients with renal replacement therapy such as hemodialysis, peritoneal dialysis, and kidney transplantation; 4. Women who are pregnant, planning to become pregnant or breastfeeding; 5. Those who are allergic to the test drug; 6. Those who are participating in clinical trials of other drugs or have participated in other clinical trials within 3 months; 7. The researchers believe that other reasons are not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated rate of glomerular filtration rate decline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Random urine protein-to-creatinine ratio;full segment parathyroid hormone;Urinary kidney injury factor-1;Urinary neutrophil gelatinase-associated lipocalin;Intestinal flora metabolomics;Blood calcium concentration;kidney function(SCR BUN);24-hour urine protein quantification;Hemoglobin;Serum albumin;incidence of endpoint events;Blood phosphorus concentration;Serum transferrin;TCM syndrome score;Prealbumin;Serum ferritin;Erythropoietin; | — |
Countries
China
Contacts
Public ContactNie Xiaoli
Southern Medical University Sinowest Medical Hospital
Outcome results
None listed